MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC OXYGEN CHAMBER; CHAMBER, HYPERBARIC

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

No harm to patient.Treatment was complete when system error "e301" and alarm occurred.Patient safely removed from chamber and transported on the gurney to an adjoining room.Notified the national safety director of an acute and chronic wound care organization.Discussed events with service technician for the manufacturer.Chamber run through five cycles at varying depths and rates as advised by the manufacturer without duplication of error.Chamber not removed from unit, however, signage was placed on machine to remove from service until inspected.

• Brand Name: HYPERBARIC OXYGEN CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 east la palma ave.; anaheim CA 92807
• MDR Report Key: 6002532
• MDR Text Key: 56566335
• Report Number: 6002532
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68